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Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease

NCT01168440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-09-13

No results posted yet for this study

Summary

VHL patients may benefit from sunitinib. This study will investigate the following objectives :

PRIMARY OBJECTIVE

* To determine the objective response rate according to RECIST criteria, in VHL patients with advanced tumors or tumors untreatable by other means, and treated with sunitinib.

SECONDARY OBJECTIVES

* To evaluate the safety and tolerability of sunitinib in VHL patients according to the NCI-CTC criteria Version 3.0.
* To determine the following time-to-event endpoints: overall survival, time to disease progression, progression free survival, time to response and duration of response.
* To evaluate quality of life in VHL patients receiving sunitinib.

Conditions

  • Von Hippel-Lindau Disease

Interventions

DRUG

Sunitinib

Sunitinib, 50 mg PO daily, 6 weeks courses with schedule 4/2 (4 weeks of treatment followed by 2 weeks of rest).

Sponsors & Collaborators

  • Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

    lead OTHER

Principal Investigators

  • Stephane RICHARD, MD, PhD · Hôpital Kremlin-Bicêtre (France)

  • Reza T ELAIDI, PhD · ARTIC (Hopital Européen Georges Pompidou, FRANCE)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01168440 on ClinicalTrials.gov